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Screening Women With Prior HPV for Anal Neoplasia

NCT05217940 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-22

No results posted yet for this study

Summary

The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

Conditions

  • HPV-related Lower Genital Tract Neoplasias
  • HPV-related Anal Neoplasias
  • Early Stage Lower Genital Tract Cancers

Interventions

DIAGNOSTIC_TEST

Diagnostic tests for anal cancer screening

The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.

Sponsors & Collaborators

Principal Investigators

  • Keith Sigel, MD, PhD, MPH · Icahn School of Medicine at Mount Sinai

  • Elizabeth Chiao, MD · M.D. Anderson Cancer Center

  • Ashish Deshmukh, PhD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217940 on ClinicalTrials.gov